News

An FDA Drug Safety Communication sent to healthcare professionals states that Dasatinib (Sprycel, Bristol-Myers Squibb) may increase the risk of pulmonary arterial hypertension.

FDA has approved sitagliptin and simvastatin (Juvisync, MSD International GmbH Clonmel), a fixed-dose combination prescription medication that contains 2 previously approved medications in 1 tablet for use by adults who need both sitagliptin and simvastatin.

FDA has approved tadalafil (Cialis, Eli Lilly) for 3 indications: ED, the signs and symptoms of BPH, and ED and the signs and symptoms of BPH in men who have both conditions.

Drug companies sponsoring human trials of possible new medications have ethical responsibilities to study participants and to science to disclose the results of their clinical research, even when product development is no longer being pursued.

New molecular entity: Ticagrelor tablets were FDA approved to reduce rate of thrombotic cardiovascular events in patients with ACS.

Dapagliflozin is a sodium glucose co-transporter inhibitor under review for FDA approval for the treatment of type 2 diabetes mellitus. Despite the availability of many antidiabetic agents in the United States, type 2 diabetes remains inadequately controlled in many patients.

FDA is requiring the zoledronic acid (Reclast, Novartis) prescribing information to now include a warning not to use the drug in those with renal dysfunction.

It's flu season again, which always focuses public attention on the reliablity and availability of the nation's vaccine supply.

In sexually active partners, early treatment with antiretroviral therapy compared to delayed treatment decreased the risk of genetically linked HIV-1 transmission to the uninfected partner.

Axitinib, an investigational selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3 significantly extended progression-free survival compared with sorafenib in patients with previously treated metastatic renal cell carcinoma.

Diarrhea-associated healthcare utilization and treatment costs for US children <5 years of age

Recent FDA action (through September 2011) related to golimumab expanded label, meningococcal and Hib combination vaccine, desvenlafaxine, rivaroxaban anticoagulant, deferiprone oral iron chelator, glucarpidase experimental treatment, doxidopa, QLT091001, NP-001, cyclophosphamide, resminostat oral pan HDAC inhibitor, TXA127

New molecular entity: Rivaroxaban was FDA approved for prevention of deep vein thrombosis.

In a safety communication released September 7, 2011, FDA announced it is requiring the prescribing information for all tumor necrosis factor-alpha blockers to include a black-boxed warning regarding an increased risk of infection from 2 bacterial pathogens, Legionella and Listeria.

National Heart, Lung, and Blood Institute-sponsored cardiovascular trials often enroll a "substantial" proportion of international participants.

Biologic agents have no effect on the rate of major adverse cardiovascular events in patients suffering from chronic plaque psoriasis.

The importance of ensuring that pharmacist-provided clinical services are represented in the electronic health record has come to the forefront with the Pharmacy e-Health Information Technology Collaborative.

In patients with psoriasis or rheumatoid arthritis, the use of tumor necrosis factor inhibitors or hydroxychloroquine, but not methotrexate, was associated with a decrease in the incidence of diabetes compared to other disease-modifying antirheumatic drugs.

Recent FDA Approvals (through September 2011) related to Remicade, Prolia, haloperidol injection, Soliris

Osteoporosis is a widespread condition with significant morbidity and mortality affecting millions of people in the United States and worldwide. Incidence is expected to increase as the population ages.

A wave of consolidation among providers is being blamed for driving up costs.

Large health plans across the country are diving into accountable care with some degree of success.

Four-tier formularies have emerged as one method to control the rising costs associated with specialty pharmaceuticals.

The National Association of Boards of Pharmacy has developed a platform for sharing prescription monitoring programs

Insurers must invent new healthcare solutions to be competitive in the market emerging under the Patient Protection and Affordable Care Act, according to a new report.

Edith Rosato will take over for long-time CEO Judith Cahill, who announced retirement plans earlier this year.

Nonsteroidal anti-inflammatory drugs (NSAIDs) should be used with caution during pregnancy, as exposure may increase the risk of spontaneous abortion, reported a study published online September 6 in the Canadian Medical Association Journal.

An interaction between warfarin and acetaminophen may result in significant elevations of international normalized ratio (INR), putting patients at increased risk for hemorrhagic complications.

FDA has notified healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNFα) blockers has been updated to include the risk of infection from 2 bacterial pathogens, Legionella and Listeria.

FDA has issued a complete response letter for a golimumab (Simponi, Janssen Biotech) supplemental Biologics License Application seeking an expanded label in the treatment of active psoriatic arthritis.